The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Alpha Amylase.
| Device ID | K872831 |
| 510k Number | K872831 |
| Device Name: | BIOTROL ALPHA AMYLASE |
| Classification | Saccharogenic, Amylase |
| Applicant | BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-17 |
| Decision Date | 1987-09-04 |